Impact of Direct Current Electrical Stimulation on Treatment of Lumbosacral Radiculopathy

Part of paid clinical trials in Escondido, California.

Sponsor
NeuFit - Neurological Fitness and Education
Study ID
NCT06421558
Status
Recruiting
Apply to this trial

Conditions

  • Radiculopathy Lumbar
  • Radiculopathy Multiple Sites
  • Radiculopathy Sacral

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neubie Direct Current Electrical Stimulation Device — DEVICE
    Direct Current Electrical Stimulation Device that uses electrodes non-invasively on the skin to stimulate muscle fibers.
  • Transcutaneous Electrical Stimulation — DEVICE
    Transcutaneous Electrical Nerve Stimulation device - uses alternating current delivered through electrodes on the skin.

Study Details

This study will compare two methods of electrical stimulation (alternating current and direct current) as an adjunctive therapy to treating lumbosacral radiculopathy. Both types of electrical stimulation have been used in clinical practice for physical therapy, however direct current stimulation is much less common and there is less known about its impact on physical therapy outcomes. The aim of this project is to show the efficacy of a novel device, the Neubie direct current device, compared to traditional TENS unit in clinical physical therapy treatment of radiculopathy. Outcomes measured will include: pain intensity, functional status, neurological status, electrophysiological changes and patient satisfaction.

Key Dates

Start date
Apr 1, 2024
Status verified
Jul 2024
Primary completion
May 1, 2025
Completion
Aug 1, 2025

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Neubie Direct Current Electrical Stimulation Device
    The experimental group subjects follow with 12 sessions of physical therapy over a 6-week period which include 30 min of various physical therapy exercises with the Neubie.
  • Other: Transcutaneous Electrical Stimulation
    The control group subjects follow with 12 sessions of physical therapy over a 6-week period which include: a 30-min of various physical therapy exercises with TENS application.

Primary Outcome Measure

H-Reflex [ Time Frame: Pre-intervention ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
NCEPT Physical TherapyEscondidoCalifornia92025
Dimitrios Kostopolous
[email protected]
APEX Physical TherapyCape CoralFlorida33991
Dimitrios Kostopolous
[email protected]
Catalyst Physical TherapyClearwaterFlorida33756
Dimitrios Kostopolous
[email protected]
APEX Physical TherapyFort MyersFlorida33908
Dimitrios Kostopolous
[email protected]
Kinetix Arbor Greens - JonesvilleGainesvilleFlorida32669
Dimitrios Kostopolous
[email protected]
Kinetix Haile PlantationGainesvilleFlorida32608
Dimitrios Kostopolous
[email protected]
Adams Physical Therapy ServicesPortlandIndiana47371
Dimitrios Kostopolous
[email protected]
KORT BardstownBardstownKentucky40004
Dimitrios Kostopolous
[email protected]
KORT SheperdsvilleShepherdsvilleKentucky40165
Dimitrios Kostopolous
[email protected]
Hands On Physical TherpayAstoriaNew York11106
Dimitrios Kostopoulos, MD, PhD, DPT
[email protected]
917-538-2242
WellHealth Physical TherapyDeer ParkNew York11729
Dimitrios Kostopolous
[email protected]
WellHealth Physical TherapyHicksvilleNew York11801
Dimitrios Kostopolous
[email protected]
Hands On Physical Therapy of Queens VillageQueens VillageNew York11428
Dimitrios Kostopolous, MD, PhD, DPT
[email protected]
917-538-2242
Courcier ClinicEdmondOklahoma73013
Dimitrios Kostopolous
[email protected]
Spine & Rehab SpecialistsEl PasoTexas79925
Dimi Kostopolous
[email protected]
Spine & Rehab SpecialistsEl PasoTexas79936
Dimitrios Kostopoulos
[email protected]

Find similar trials in Escondido, CA

By research site
NCEPT Physical Therapy· Escondido, CAAPEX Physical Therapy· Cape Coral, FLCatalyst Physical Therapy· Clearwater, FLAPEX Physical Therapy· Fort Myers, FLKinetix Arbor Greens - Jonesville· Gainesville, FLKinetix Haile Plantation· Gainesville, FL

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